Availability of medicines before and during crises

The European Medicines Agency (EMA) plays a key role in coordinating the European Union's (EU) response to medicine supply issues caused by crises such as major events or public health emergencies. EMA also has an important role in monitoring medicine shortages that cannot be resolved through measures taken at national level and that might lead to a crisis situation.

EMA has two bodies to carry out its crisis preparedness and management responsibilities:

• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
• Medicines Shortages Single Point of Contact (SPOC) Working Party

For more information, see: 

• Crisis preparedness and management

Also on this topic

• Union list of critical medicines

EU actions on anti-D immunoglobulins supply chain

EMA and the Heads of Medicines Agencies (HMA) have issued a set of recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

Injections of anti-D immunoglobulins during pregnancy are the only medicine available to prevent Rhesus disease immunisation in pregnant people.

The only source for manufacturing these medicines is plasma (i.e., the liquid part of the blood) collected from donors and containing the anti-D immunoglobulin.

However, the number of donors is declining and production is limited to a small number of non-EU countries.

These medicines are part of the Union list of critical medicines.

Recommendations

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) issued a set of recommendations to:

• EU Member States - developing action plans and supporting research to find therapeutic alternatives and secure the supply of anti-D immunoglobulins in the EU.
• The European Commission - identifying measures to ensure the continuous supply of these medicines and to support and coordinate the activities of Member States.
• The plasma industry and research organisations - ensuring the adequate supply of anti-D immunoglobulins in the EU, including through optimising manufacturing capacity and developing appropriate alternatives.

To find the full recommendations, see the document available below:

Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products to address anti-D immunoglobulin supply chain vulnerabilities

Reference Number: EMA/135603/2025

EU actions on radiopharmaceutical supply chain issues

EMA and the Heads of Medicines Agencies (HMA) have issued a set of recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals.

Radiopharmaceuticals are substances that contain radioactive compounds. They play a key role in medical diagnosis and treatment, such as cancer treatment.

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) tailored these recommendations for stakeholders such as the European Commission, EU Members States and pharmaceutical industry. They include:

• Increasing the EU's domestic capabilities, such as production facilities
• Mapping supply chains
• Coordinating transport solutions
• Including radiopharmaceuticals in so-called horizon scanning activities

Regulatory measures alone are insufficient to strengthen the supply chain of radiopharmaceuticals. Other long-term industrial policy measures are also required.

Supply chain vulnerabilities

The increasing use of radiopharmaceuticals and Europe's limited manufacturing capacity have led to occasional shortages in EU Member States.

The main vulnerabilities in the supply chain are:

• Dependency on third countries to source stable isotopes and other materials
• Ageing research reactors in the EU
• A complex supply chain, including challenges in the safe transport of radiopharmaceuticals

Recommendations

EMA and HMA issued their recommendations to strengthen the supply of radiopharmaceuticals in April 2025. 

They are available below:

Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals

Reference Number: EMA/95894/2025

EU actions on shortages of GLP-1 receptor agonists

EMA and the Heads of Medicines Agencies (HMA) are taking action to tackle shortages of glucagon-like peptide-1 (GLP-1) receptor agonists in the EU.

This includes providing recommendations that different stakeholders can take and coordinating EU actions via the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and the Medicine Shortages Single Point of Contact (SPOC) Working Party.

These medicines include:

• Ozempic (semaglutide)
• Saxenda (liraglutide)
• Trulicity (dulaglutide)
• Victoza (liraglutide)

A surge in demand for some of these medicines since 2022, along with manufacturing capacity constraints, is causing shortages across the EU. 

GLP-1 receptor agonists are authorised for the treatment of diabetes or for weight management under certain conditions, or both. 

Recommended stakeholder actions

The MSSG has developed recommendations for actions that EU Member States and marketing authorisation holders can take to help tackle GLP-1 receptor agonist shortages.

In addition, the MSSG also urges healthcare professionals and the public to follow key recommendations. 

To view the specific recommendations for each stakeholder group, please select the corresponding stakeholder type from the expandable panels below.

EU Member States

• Consider measures with marketing authorisation holders to control and optimise medicine distribution. The MSSG will monitor the situation and impact of measures through the Medicine Shortages Single Point of Contact Working Party
• Develop guidelines to prioritise patients with the greatest need for these medicines, together with experts and learned societies

Marketing authorisation holders

• Increase manufacturing capacity and engage with regulatory authorities to ensure coordination
• When promoting these medicines, they must only use messages that are approved by regulatory authorities and align with rational medicine use and public health goals, in line with national law
• Consider implementing awareness campaigns on weight management and educational activities about the ongoing shortages and its implications for clinical practice

Healthcare professionals

• Prescribe these medicines in line with their authorised use(s) only, taking guidance from national authorities or applicable national therapeutic guidelines

  The list below provides an overview of authorised uses:

  • Diabetes only: Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza
  • Weight management as an adjunct to diet and exercise in people who have obesity or are overweight, with weight-related health issues: Saxenda and Wegovy
  • Both diabetes and weight management under certain conditions: Mounjaro

    Any other use represents off-label use which will worsen existing shortages.

• These medicines are not approved, and should not be used, for cosmetic weight loss (i.e. use for weight loss in people without obesity or people with overweight but do not have weight-related health problems). Consider offering lifestyle advice to people in this category instead

Patients and consumers

• Only use GLP-1 receptor agonists under medical supervision. All of these medicines are prescription only medicines. Their authorised uses are listed in the 'healthcare professionals' expandable panel above. Using these medicines without medical supervision can put your health at risk.
• Beware that these medicines, like all medicines, can cause side effects. The most common are diarrhoea and nausea (feeling sick)
• Beware of the risk of substandard or falsified medicines being offered online. Using such medicines can have serious health consequences. More information on buying medicines online in the EU and how to recognise registered pharmacies is available
• If you are already being treated with a GLP-1 receptor agonist and you cannot obtain your medicine, discuss this with your doctor, who may switch you to another treatment

EU coordination

A multistakeholder workshop in July 2024 explored additional measures to improve the supply of these medicine in the European Union / European Economic Area. More information on the workshop is available on the event page:

• Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists (01/07/2024)

EMA and the European medicines regulatory network have been closely monitoring the shortages since 2022. They hold regular meetings with the marketing authorisation holders to gain a full oversight of the market, including current and anticipated shortages, and closely monitor the effects of any mitigation actions. EMA also exchanges information with its international counterparts for a global overview.

To ensure that patients receive the medicines they need, EU Member States have facilitated stock redistribution. Some Member States have also implemented tailored measures to control the supply of these medicines within their national healthcare systems.

To get a comprehensive overview of how GLP-1 receptor agonists are used in real life, the MSSG is carrying out a real-world data study via EMA's DARWIN EU.

Preventing shortages of antibiotics during winter

EMA, the Medicine Shortages Single Point of Contact Working Party (SPOC WP) and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) collaborate with key stakeholders in the supply chain to prevent and mitigate shortages of antibiotics across the EU.

This collaboration aims to prevent shortages such as those seen in the winter 2022-23. A surge in respiratory infections, coupled with manufacturing delays and production issues, led to shortages of critical antibiotics during that winter.

The focus areas include:

• increasing production and identifying alternative sources of supply;
• using regulatory flexibilities to increase supply;
• promoting the prudent use of antibiotics and emphasizing the need to avoid stockpiling;
• exchanging information with international counterparts for a global view.

For more information on the current situation in the EU, see: Amoxicillin and amoxicillin/clavulanic acid - supply shortage

Autumn and winter 2023-24

Following a surge in respiratory infections across the EU in the winter 2022-23, EMA and the European Commission’s Health Emergency Preparedness and Response Authority (HERA) collected data to estimate the supply and demand in the EU for the following antibiotics used to treat respiratory infections:

• amoxicillin
• amoxicillin/clavulanic acid
• penicillin V
• azithromycin
• clarithromycin
• ceftriaxone
• cefotaxime
• piperacillin-tazobactam

Key marketing authorisation holders provided EMA and HERA with data on supply forecasts and production capacity. EMA and HERA matched these data with demand estimates for the winter season in the EU and the European Economic Area.

In July 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission issued recommendations through MSSG. These were aimed at ensuring the availability of antibiotics in the autumn and winter of 2023-24. 

The recommendations focused on three main preventive actions:

• EMA and HERA to continue engaging with marketing authorisation holders to step up measures to increase production and supply of antibiotics.
• EMA, the European Commission and EU Member States to work together with marketing authorisation holders to monitor supply and demand.
• Communication actions to raise awareness of EU measures to prevent antibiotic shortages, promote prudent use and discourage stockpiling.

These actions had an impact on the antibiotic shortages situation in the winter 2023-24 with most EU Member States reporting a substantial improvement or resolution of shortages in January 2024.

For more information, see:

• Health Emergency Preparedness and Response Authority (HERA)
• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings
• Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (14/07/2023)

Overview of medicine lists

The table below centralises medicine lists that are currently available or being drawn up as well as lists that can be established when a specific need arises, as was the case during the COVID-19 public health emergency:

Name	Purpose	Mandate	Legal basis
Union list of critical medicines	Prevention Helping track EU manufacturing capacity Ensuring security of supply and availability of critical medicines at EU level	EMA / Heads of Medicines Agencies (HMA)	Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use
List of main therapeutic groups of medicines	Crisis preparedness Supporting the preparation of critical medicine lists for a public health emergency or major event	Executive Steering Group on Shortages and Safety of Medicinal Products	Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123)
List of critical medicines for a major event	Crisis response Drawn up after a major event is declared Listing medicines needed for major events Helping closely monitor supply and demand of related medicines	Steering group on shortages and safety of medicines	Regulation (EU) 2022/123
List of critical medicines for a public health emergency	Crisis response Drawn up after a public health emergency is declared Listing medicines needed for public health emergencies Helping closely monitor supply and demand of related medicines	Steering group on shortages and safety of medicines	Regulation (EU) 2022/123

For more information, see: 

• COVID-19 public health emergency of international concern (2020-2023)
• Availability of medicines during COVID-19

List of main therapeutic groups in crisis preparedness

A list of main therapeutic groups agreed by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings enables EMA to identify the critical medicines needed in case of a specific public health emergency or major event.

It includes medicines for use in emergency care, surgery and intensive care.

List of the main therapeutic groups (MTGs) in crisis preparedness

Reference Number: EMA/243660/2022

EMA reviews the main therapeutic groups' list every year and whenever necessary to consider relevant developments, such as changes in clinical practice.

In line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123), the MSSG will draw up a list of critical medicines for each specific public health emergency or major event, and closely monitor the supply and demand of those medicines to prevent or mitigate potential shortages.

EMA can coordinate swift actions across EU Member States to ensure the continued supply of medicines in case shortages happen. 

Although marketing authorisation holders have legal reporting obligations for critical medicines under Regulation (EU) 2022/123, they do not have such obligations for medicines on the main therapeutic groups list.

The MSSG consulted widely to draw up the main therapeutic groups list, including with the Medicines Shortages Single Point of Contact (SPOC) Working Party, Patients' and Consumers' Working Party (PCWP), Healthcare Professionals' Working Party (HCPWP), learned societies and industry associations. For more information, see:

Methodology for the establishment of lists of “main therapeutic groups” in crisis preparedness and of the lists of “critical medicines” in the context of a major event and/or public health emergency

Reference Number: EMA/45332/2022

For more information, see:

• Availability of medicines during COVID-19: Critical medicines for COVID-19

Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products on the availability of a subset of antibiotics

Adopted Reference Number: EMA/312229/2023